Smart messages and alerts for an infusion delivery and management system

ABSTRACT

Method and system for providing diabetes management is provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent application Ser. No. 11/365,168 filed Feb. 28, 2006, now U.S. Pat. No. 7,981,034, the disclosure of which is incorporated herein by reference for all purposes.

BACKGROUND

With increasing use of pump therapy for Type 1 diabetic patients, young and old alike, the importance of controlling the infusion device, such as external infusion pumps, is evident. Indeed, presently available external infusion devices typically include an input mechanism such as buttons through which the patient may program and control the infusion device. Such infusion devices also typically include a user interface such as a display which is configured to display information relevant to the patient's infusion progress, status of the various components of the infusion device, as well as other programmable information such as patient specific basal profiles.

The external infusion devices are typically connected to an infusion set which includes a cannula that is placed transcutaneously through the skin of the patient to infuse a select dosage of insulin based on the infusion device's programmed basal rates or any other infusion rates as prescribed by the patient's doctor. Generally, the patient is able to control the pump to administer additional doses of insulin during the course of wearing and operating the infusion device, such as for administering a carbohydrate bolus prior to a meal. Certain infusion devices include a food database that has associated therewith, an amount of carbohydrate, so that the patient may better estimate the level of insulin dosage needed for, for example, calculating a bolus amount.

However, in general, most estimation or calculation of a bolus amount for administration, or a determination of a suitable basal profile, for that matter, are educated estimates based on the patient's physiology as determined by the patient's doctor, or an estimate performed by the patient. Moreover, the infusion devices do not generally include enhancement features that would better assist the diabetic patients to control and/or manage the glucose levels.

In view of the foregoing, it would be desirable to have an approach to provide methods and system for providing proactive notifications to the patients using infusion devices that may assist in better controlling and treating diabetes, such as, for example, by programming the pump and/or determining frequency of event occurrences that are relevant to different types of diabetes-associated episodes such as hyperglycemic state, hypoglycemic state, monitoring of glucose levels and the like.

SUMMARY OF THE INVENTION

In accordance with the various embodiments of the present invention, there are provided methods and system for notification of patient parameters and physiological states to prompt the user to take proactive measures such as additional capillary blood glucose testing, consumption of snacks, and/or other diabetes management related alerts to the patient prior to the onset of the relevant condition such that the patients may better control the glucose levels during the course of the day when using an insulin infusion pump. In addition, system and methods in accordance with the present inventions include data analysis of the patient's glucose levels over extended periods of time to generate notification to the patients to inform them of the analysis results so as to provide additional motivation or incentive to improve upon the existing glucose management.

These and other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating an insulin therapy management system for practicing one embodiment of the present invention;

FIG. 2 is a block diagram of the insulin delivery device of FIG. 1 in one embodiment of the present invention;

FIG. 3 is a flow chart illustrating a notification procedure to prevent DKA from persistent high blood glucose level in accordance with one embodiment of the present invention;

FIG. 4 is a flow chart illustrating a notification procedure for minimizing nocturnal hypoglycemia in accordance with one embodiment of the present invention;

FIG. 5 is a flow chart illustrating a notification procedure for improving blood glucose level control in a patient in accordance with one embodiment of the present invention; and

FIG. 6 is a flow chart illustrating a notification procedure for improving blood glucose level control in a patient in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram illustrating an insulin therapy management system for practicing one embodiment of the present invention. Referring to FIG. 1, the insulin therapy management system 100 includes an analyte monitoring system 110 operatively coupled to an insulin delivery device 120, which may be, in turn, operatively coupled to a remote terminal 140. As shown the Figure, the analyte monitoring system 110 is, in one embodiment, coupled to the patient 130 so as to monitor or measure the analyte levels of the patient. Moreover, the insulin delivery device 120 is coupled to the patient using, for example, an infusion set and tubing connected to a cannula (not shown) that is placed transcutaneously through the skin of the patient so as to infuse medication such as, for example, insulin, to the patient.

Referring to FIG. 1, in one embodiment the analyte monitoring system 110 in one embodiment may include one or more analyte sensors subcutaneously positioned such that at least a portion of the analyte sensors are maintained in fluid contact with the patient's analytes. The analyte sensors may include, but are not limited to, short term subcutaneous analyte sensors or transdermal analyte sensors, for example, which are configured to detect analyte levels of a patient over a predetermined time period, and after which, a replacement of the sensors is necessary.

The one or more analyte sensors of the analyte monitoring system 110 is coupled to a respective one or more of a data transmitter unit which is configured to receive one or more signals from the respective analyte sensors corresponding to the detected analyte levels of the patient, and to transmit the information corresponding to the detected analyte levels to a receiver device, and/or insulin delivery device 120. That is, over a communication link, the transmitter units may be configured to transmit data associated with the detected analyte levels periodically, and/or intermittently and repeatedly to one or more other devices such as the insulin delivery device and/or the remote terminal 140 for further data processing and analysis.

The transmitter units of the analyte monitoring system 110 may in one embodiment be configured to transmit the analyte related data substantially in real time to the insulin delivery device 120 and/or the remote terminal 140 after receiving it from the corresponding analyte sensors such that the analyte level, such as glucose level, of the patient 130 may be monitored in real time. In one aspect, the analyte levels of the patient may be obtained using one or more of a discrete blood glucose testing device, such as blood glucose meters, or a continuous analyte monitoring system, such as continuous glucose monitoring systems.

Additional analytes that may be monitored, determined or detected the analyte monitoring system 110 include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be determined.

Moreover, within the scope of the present invention, the transmitter units of the analyte monitoring system 110 may be configured to directly communicate with one or more of the remote terminal 140 or the insulin delivery device 120. Furthermore, within the scope of the present invention, additional devices may be provided for communication in the analyte monitoring system 100 including additional receiver/data processing unit, remote terminals (such as a physician's terminal and/or a bedside terminal in a hospital environment, for example). In addition, within the scope of the present invention, one or more of the analyte monitoring system 110, the insulin delivery device 120 and the remote terminal 140 may be configured to communicate over a wireless data communication link such as, but not limited to, RF communication link, Bluetooth® communication link, infrared communication link, or any other type of suitable wireless communication connection between two or more electronic devices, which may further be uni-directional or bi-directional communication between the two or more devices. Alternatively, the data communication link may include wired cable connection such as, for example, but not limited to, RS232 connection, USB connection, or serial cable connection.

The insulin delivery device 120 may include in one embodiment, but is not limited to, an external infusion device such as an external insulin infusion pump, an implantable pump, a pen-type insulin injector device, a patch pump, an inhalable infusion device for nasal insulin delivery, or any other type of suitable delivery system. In addition, the remote terminal 140 in one embodiment may include for example, a desktop computer terminal, a data communication enabled kiosk, a laptop computer, a handheld computing device such as a personal digital assistant (PDA), or a data communication enabled mobile telephone.

Referring back to FIG. 1, in one embodiment, the analyte monitoring system 100 includes a strip port configured to receive a test strip for capillary blood glucose testing. In one aspect, the glucose level measured using the test strip may in addition, be configured to provide periodic calibration of the analyte sensors of the analyte monitoring system 100 to assure and improve the accuracy of the analyte levels detected by the analyte sensors.

FIG. 2 is a block diagram of an insulin delivery device of FIG. 1 in one embodiment of the present invention. Referring to FIG. 2, the insulin delivery device 120, in one embodiment, includes a processor 210 operatively coupled to a memory unit 240, an input unit 220, a display unit 230, an output unit 260, and a fluid delivery unit 250. In one embodiment, the processor 210 includes a microprocessor that is configured to and capable of controlling the functions of the insulin delivery device 120 by controlling and/or accessing each of the various components of the insulin delivery device 120. In one embodiment, multiple processors may be provided as a safety measure and to provide redundancy in case of a single processor failure. Moreover, processing capabilities may be shared between multiple processor units within the insulin delivery device 120 such that pump functions and/or control may be performed faster and more accurately.

Referring back to FIG. 2, the input unit 220 operatively coupled to the processor 210 may include a jog dial, key pad buttons, a touch pad screen, or any other suitable input mechanism for providing input commands to the insulin delivery device 120. More specifically, in case of a jog dial input device, or a touch pad screen, for example, the patient or user of the insulin delivery device 120 will manipulate the respective jog dial or touch pad in conjunction with the display unit 230 which performs as both data input and output units. The display unit 230 may include a touch sensitive screen, an LCD screen, or any other types of suitable display units for the insulin delivery device 120 that are configured to display alphanumeric data as well as pictorial information such as icons associated with one or more predefined states of the insulin delivery device 120, or graphical representation of data such as trend charts and graphs associated with the insulin infusion rates, trend data of monitored glucose levels over a period of time, or textual notification to the patients.

Referring to FIG. 2, the output unit 260 operatively coupled to the processor 210 may include an audible alarm including one or more tones and/Nor preprogrammed or programmable tunes or audio clips, or vibratory alert features having one or more pre-programmed or programmable vibratory alert levels. In one embodiment, the vibratory alert may also assist in priming the infusion tubing to minimize the potential for air or other undesirable material in the infusion tubing. Also shown in FIG. 2 is the fluid delivery unit 250 which is operatively coupled to the processor 210 and configured to deliver the insulin doses or amounts to the patient from the insulin reservoir or any other types of suitable containment for insulin to be delivered (not shown) in the insulin delivery device 120 via an infusion set coupled to a subcutaneously positioned cannula under the skin of the patient.

Referring yet again to FIG. 2, the memory unit 240 may include one or more of a random access memory (RAM), read only memory (ROM), or any other types of data storage units that is configured to store data as well as program instructions for access by the processor 210 and execution to control the insulin delivery device 120 and/or to perform data processing based on data received from the analyte monitoring system 110, the remote terminal 140, the patient 130 or any other data input source.

FIG. 3 is a flow chart illustrating a notification procedure to prevent diabetic ketoacidosis (DKA) from persistent high blood glucose level in accordance with one embodiment of the present invention. Referring to FIG. 3, in one embodiment of the present invention, the insulin delivery device 120 may be programmed such that at step 310, a predetermined number of consecutive glucose readings is received over a predefined period of time. The glucose readings may be received from the analyte monitoring system 110 and stored, for example, in the memory unit 240 of the insulin delivery device 120. For example, in one embodiment, the patient may be prompted to provide a predetermined number, such as three, of consecutive readings of blood glucose measurements over the predefined time period such as within a thirty minute window to a four hour window.

Within the scope of the present invention, the insulin delivery device 120 may be configured to ascertain these consecutive glucose readings from the data stream received from the analyte monitoring system 110. Moreover, the predefined time period may additionally include any other suitable time period where the monitored analyte levels may provide information associated with the patient's physiological condition as pertains to the insulin therapy and diabetes management. For example, the predefined time period may include a 4-7 day period (or longer or shorter as may be appropriate), where the insulin delivery device 120 may be configured to receive the glucose readings at a specific time of the day (for example, at 7 am in the morning). In this case, the consecutive glucose readings may include each measured glucose level at 7 am in the morning for the 4-7 day period.

Referring to FIG. 3, at step 320, a predetermined target high glucose level which is pre-programmed and pre-stored in the memory unit 240 of the insulin delivery device 120, for example, may be retrieved by the processor 210 of the insulin delivery device 120. Alternatively, the patient may be prompted to provide a suitable target high glucose level at step 320 by the insulin delivery device 120. Thereafter, at step 330, the consecutive glucose readings over the predefined time period received at step 310 are compared with the target high glucose level from step 320. If it is determined at step 330 that the predetermined number of consecutive glucose readings over the predefined time period are not equal to or greater than the target high glucose level retrieved from step 320, then at step 350, the predefined time period may be optionally reset, and the routine returns to step 310. For example, the system may be configured to wait for the subsequent predefined time period, for example, between a time period of 30 minutes to one or two hour windows depending upon the time of the day and also, depending upon the time of the day in close proximity to a meal or physical activity, as may be programmed by the patient or the patient's physician or care provider, before executing the routine as described in FIG. 3 again.

Referring back to FIG. 3, if, at step 330, it is determined that the predetermined number of consecutive glucose readings over the predefined time period is greater or equal to the predetermined target high glucose level retrieved from memory unit 240 (FIG. 2), or received from the patient via the input unit 220 (FIG. 2) at step 320, then at step 340, an alert or notification is generated and output to the patient, either visually, audibly, tactily, or any combination of the output mechanism such as a visual alert displayed on the display unit 230 in combination with a vibratory alert providing tactile notification to the patient, and/or an audible alert. In one embodiment, the output alert notification provided to the patient may include a warning notification that the patient's consecutive blood glucose readings are persistently above the predetermined or programmed target high glucose level, and also provide a recommendation to take possible corrective or confirmatory actions such as intake of insulin, and/or additional glucose testing such as, for example, using fingerstick capillary blood glucose measurements. By way of an example, the insulin delivery device 120 may be configured to display a notification such as, but not limited to:

-   -   “3 High BGs in a Row—Consider Insulin Injection and Site         Change”,     -   “Test Ketones”,     -   “If vomiting Go to Emergency Room”,     -   “Take Insulin Bolus”,     -   “Change Infusion Site”,     -   “Retest Glucose Level in 30 Minutes”,     -   “Call Doctor if Glucose Remains Elevated”,         or any other suitable notification that may assist the patient         in preventing diabetic ketoacidosis (DKA) which is associated         with disruption of insulin delivery. As it is important for         patients using insulin delivery device 120 to prevent going into         DKA on the delivery device 120, the notification may be         accompanied by one or more associated audible or tactile alerts         such that the patients are readily and quickly able to ascertain         the condition for which the insulin delivery device 120 is         prompting the patients, and to take corrective actions         immediately or as soon as possible.

Referring to FIG. 3, in one embodiment, the predetermined target high glucose level stored in the memory unit 240 of the insulin delivery device 120 may be 250 mg/dL, and which may be adjustable by the patient or the patient's care provider. For example, a diabetic patient experiencing thirst and irritation which are generally symptoms of elevated glucose readings, at 2 pm, determines, based on measured glucose readings (for example, received from the analyte monitoring system 110), that the glucose level is at 263 mg/dL. The patient has programmed the insulin delivery device 120 to a target high glucose level of 250 mg/dL, with a predetermined number of consecutive glucose readings at two readings, and the predefined time period to be a 2 hour window.

With the initial glucose reading of 263 mg/dL, the patient may initially be prompted to trouble shoot certain settings of the delivery device 120, for example, to confirm that the lunch bolus was delivered, no additional carbohydrate was ingested, verify the infusion tubing (fluid delivery unit 250) for possible air bubbles. If all settings are in their accurate modes, then a correction bolus may be administered using the insulin delivery device 120. Thereafter, the glucose level after 2 hours is retrieved, for example, from the memory unit 240 as received from the analyte monitoring system 110 (including, a separate real time capillary blood fingerstick testing, for example), and compared with the target high glucose level of 250 mg/dL. If it is determined that the second glucose measurement is still above the 250 mg/dL level, then the patient is provided with one or more of the alerts or notifications as described above to troubleshoot the persistent high glucose level condition, and thus take corrective measures to avoid the onset of DKA condition.

Referring yet again to FIG. 3, while the above description of processes and routines related to preventing DKA is provided in the context of the insulin delivery device 120, within the scope of the present invention, the calculation, determination or any programming and data processing to achieve the functions as set forth in FIG. 3 may be performed either alternately or in conjunction with the insulin delivery device 120, by the analyte monitoring system 110, or the remote terminal 140, as may be convenient or practical to the patient 130.

FIG. 4 is a flow chart illustrating a notification procedure for minimizing nocturnal hypoglycemia in accordance with one embodiment of the present invention. Referring to FIG. 4, at step 410 a pre-sleep mode is detected. That is, the insulin delivery device 120 may be configured to automatically enter the pre-sleep mode based on a clock mechanism in the insulin delivery device 120 which provides real time timing data, and further, in conjunction with the patient specified meal and sleep schedule as they may be individual and different from patient to patient. For example, the patient using the insulin delivery device 120 may program a pre-sleep mode to be defined as a time period post dinner or the last meal of the day, and prior to the patient sleeping. One example may be the time period of 9 pm to midnight, with the assumption that the patient has consumed dinner or the last substantial carbohydrate intake two to three hours prior to the onset of the pre-sleep mode time period of 9 pm.

Referring to FIG. 4, upon initiation or detection of the pre-sleep mode at step 410, the insulin delivery device 120 in one embodiment is configured to retrieve consecutive glucose readings during the pre-sleep mode time period for example, from the analyte monitoring system 110 (FIG. 1). In one embodiment, the number of predetermined consecutive glucose readings received at step 420 may include three consecutive readings, two consecutive readings, or any other suitable number of consecutive readings that may be appropriate to detecting the potential onset of hypoglycemic condition.

After receiving the predetermined consecutive glucose readings during the pre-sleep time period at step 420, a predetermined and/or pre-programmed target low glucose level is retrieved from, for example, the memory unit 240 of the insulin delivery device 120 (FIG. 2) at step 430. Thereafter, at step 440, the predetermined number of consecutive glucose readings are each compared with the predetermined target low glucose level (for example, 80 mg/dL). If it is determined that one or more of the predetermined number of consecutive glucose readings during the pre-sleep time period is higher than the predetermined target low glucose level at step 440, then the routine returns to step 410 and awaits to enter the subsequent pre-sleep mode initiation.

On the other hand, referring back to FIG. 4, if at step 440 it is determined that each of the predetermined number of consecutive glucose readings during the pre-sleep time period is lower or equal to the predetermined target low glucose level, then at step 450, an alert and/or notification is generated and output to the patient to take certain predefined and appropriate corrective actions and device status verifications. Examples of such alerts and/or notifications may include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose levels, and a suggestion or recommendation to ingest a snack and or modify the existing basal rate of the insulin delivery device 120 prior to going to sleep.

In this manner, in one embodiment of the present invention, early onset of nocturnal hypoglycemic state may be detected and the patient may be notified prior to going to sleep to take one or more certain appropriate corrective actions to prevent entering into hypoglycemic state while sleeping. Suitable alerts or notifications include, for example, but are not limited to, the following:

-   -   “Three Pre-sleep Low BGs in a Row—Check Bedtime Basal”,     -   “Consider Basal Adjustment”,     -   “Eat a Bedtime Snack”

In the manner described above, in accordance with one embodiment of the present invention, there is provided an approach to prevent or minimize the potential for nocturnal hypoglycemia for the Type-1 diabetic patient. Moreover, while the above description of processes and routines related to minimizing nocturnal hypoglycemia is provided in the context of the insulin delivery device 120, within the scope of the present invention, the calculation, determination or any programming and data processing to achieve the functions as set forth in FIG. 3 may be performed either alternately or in conjunction with the insulin delivery device 120, by the analyte monitoring system 110, or the remote terminal 140, as may be convenient or practical to the patient 130.

FIG. 5 is a flow chart illustrating a notification procedure for improving blood glucose level control in a patient in accordance with one embodiment of the present invention. Referring to FIG. 5, at step 510 insulin delivery device 120 may be configured to retrieve a first glucose data set based on measured glucose levels of the patient 130 for a first predetermined time period (which may be a 7 day period, for example). Thereafter at step 520, a first running average glucose level is determined based on the first date set for the first predetermined time period. The calculated first running average glucose level may be optionally stored in the memory unit 240 of the insulin delivery device 120.

Referring back to FIG. 5, after determining the first running average glucose level for the first predetermined time period at step 520, a second glucose data set is retrieved at step 530, which corresponds to the measured glucose levels of the patient 130 for a second predetermined time period (for example, a 30 day period). Thereafter, at step 540, a second average glucose level based on the second glucose data set is determined for the second predetermined time period. Again, optionally, the calculated second average glucose level may be stored in the memory unit 240 of the insulin delivery device 120.

Thereafter, referring again to FIG. 5, at step 550, the first average glucose level is compared with the second average glucose level. If it is determined at step 550 that the first average glucose levels is not less than the second average glucose level, then the routine terminates. On the other hand, if at step 550, it is determined that the first average glucose level calculated based on the first predetermined time period is less than the second average glucose level calculated over the second predetermined time period, then at step 560, a predetermined target low glucose level is retrieved (for example, from memory unit 240), and at step 570 the retrieved predetermined target low glucose level is compared with the first average glucose level calculated at step 520. In one embodiment, the predetermined target low glucose level may be set by the patient or the patient's care provider at a suitable level, such as, for example, but not limited to, 80 mg/dL.

If at step 570 it is determined that the first average glucose level calculated for the first predetermined time period is greater than the retrieved predetermined target low glucose level, then at step 580, an appropriate notification is generated and output to the patient on one or more of the output unit 260 or the display unit 230 of the insulin delivery device 120. An example of such notification may include “Congratulations!—better BG control than Last Week,” or “Good BG Control is Worth the Effort!”.

In this manner, one or more of notifications providing encouragements to the patients may be provided based on monitored glucose levels so that the patients continue to make efforts in controlling and improving their blood glucose levels. Moreover, while 7 days and 30 days are described as the predetermined first and second time period, respectively, within the scope of the present invention, these time periods may be altered as suited to each patient and as appropriate so as to accurately and effectively evaluate monitored glucose levels of the patients over extended periods of time and to provide notifications to the patients. Moreover, within the scope of the present invention, the calculation, determination or any programming and data processing to achieve the functions as set forth in FIG. 5 may be performed either alternately or in conjunction with the insulin delivery device 120, by the analyte monitoring system 110, or the remote terminal 140, as may be convenient or practical to the patient 130.

FIG. 6 is a flow chart illustrating a notification procedure for improving blood glucose level control in a patient in accordance with another embodiment of the present invention. Referring to FIG. 6, at step 610, a first glucose data set corresponding to the measured glucose levels of the patient 130 is retrieved, for example, from the memory unit 240 of the insulin delivery device 120 as received from, for example, the analyte monitoring system 110 (FIG. 1) for a predetermined time period (such as 7 days, for example). Thereafter, a first standard deviation is determined at step 620 based on the first glucose data set. Thereafter, a second glucose data set for a second predetermined time period (such as 30 days, for example) is retrieved at step 630, and a second standard deviation based on the second glucose data set is determined at step 640.

Referring to FIG. 6, after determining the first and second standard deviations based on the first glucose data set and the second glucose data set, respectively, at step 650, the first standard deviation is compared with the second standard deviation. If at step 650 the first standard deviation is not less than the second standard deviation, then the routine terminates. On the other hand, if at step 650 it is determined that the first standard deviation is less than the second standard deviation, then at step 660, an output notification is generated and output to the patient on one or more of the output unit 260 or the display unit 230. Examples of the output notification may include, for example, a notification including “Congratulations!—Fewer Highs and Lows Than Last Week!” or “Good BG Control is Important!”, or any other suitable notification which corresponds to the glucose level standard deviations determined and compared based on the patient's monitored glucose levels.

Optionally, within the scope of the present invention, the step outputting the generated notification may be performed upon the first reactivation of the insulin delivery device 120 after the routine in FIG. 6 is performed. In this manner, the insulin delivery device 120 may be configured to provide one or more notifications based on the patient's monitored glucose levels, and to assist the patient 130 in continuing to improve monitoring and management of the glucose levels.

In a further embodiment, the patient's analyte levels may be monitored over an extended time period such as over a 4-7 day period (for example), at a specific time of the day (for example, at 7 am every morning), and the system may be configured to analyze the obtained or monitored analyte levels each day at the specified time of day to determine or generate one or more appropriate patient notifications or alerts to be provided to the patient. In this manner, the patient may be able to improve insulin therapy and diabetes management.

Moreover, within the scope of the present invention, the calculation, determination or any programming and data processing to achieve the functions as set forth in FIG. 6 may be performed either alternately or in conjunction with the insulin delivery device 120, by the analyte monitoring system 110, or the remote terminal 140, as may be convenient or practical to the patient 130. In addition, in the manner described above, any other types of glucose related data may be monitored or analyzed over a period of time in conjunction with the basal profile of the patient 130 to provide a comprehensive insulin therapy management and diabetes care system.

The various processes described above including the processes performed by the processor 210 in the software application execution environment in the insulin delivery device 120 as well as any other suitable or similar processing units embodied in the analyte monitoring system 110 and the remote terminal 140, including the processes and routines described in conjunction with FIGS. 3-6, may be embodied as computer programs developed using an object oriented language that allows the modeling of complex systems with modular objects to create abstractions that are representative of real world, physical objects and their interrelationships. The software required to carry out the inventive process, which may be stored in the memory unit 240 (or similar storage devices in the analyte monitoring system 110 and the remote terminal 140) of the processor 210, may be developed by a person of ordinary skill in the art and may include one or more computer program products.

Accordingly, a method of diabetes management in one embodiment of the present invention includes comparing each of a predetermined number of consecutive analyte related levels for a predefined time period to a predetermined target level, and generating an alert when each of the predetermined number of consecutive analyte related levels deviates from the predetermined target level.

The method may further include the step of measuring an analyte level of a patient to determine the one or more of the predetermined number of consecutive analyte related levels, where the measuring step may, in one embodiment, include the step of using one or more of a discrete blood glucose meter or a continuous analyte monitoring system.

The method may further include the step of outputting the alert on an infusion device.

Moreover, in one embodiment, the predefined time period may include one of a time period between 30 minutes and four hours.

The predetermined number of consecutive analyte related levels in another aspect may include one of two, three, four or five analyte related levels.

Additionally, the predetermined target level may include a target high analyte level.

The analyte levels may include glucose levels, and the predetermined target level may include a target high glucose level.

The alert may, in one embodiment, include one or more of an audible alert, a visual alert, or a tactile alert, where the visual alert may include one or more of an alphanumeric output display, a graphical output display, an icon display, a video output display, a color display and an illumination display.

The color display may include a change in color of an output image, animation, or background of the display unit 230, for example, and the illumination display may include, for example, but is not limited to, a persistent or sequential flashing of the backlight feature on the display unit 230.

The method may further include the step of outputting the generated alert.

The predefined time period, in one embodiment, may include a pre-sleep time period, which, in one embodiment, may be configured to begin at approximately a predetermined number of hours past the last meal of the day, and to terminate at the beginning of entering sleep cycle.

Alternatively, the pre-sleep time period may be configured to begin at approximately 9 pm and to terminate at approximately 12 am in a 24 hour daily time period.

Alternatively, the pre-sleep time period maybe configured to begin at approximately 9 pm and to terminate at approximately at 12 am in a 24 hour daily time period.

In a further aspect, the predetermined target level may include a target low analyte level, where the alert may be generated when each of the predetermined number of analyte related levels falls below the target low analyte level.

A system for providing diabetes management in accordance with another embodiment of the present invention includes an interface unit configured to receive one or more analyte related data, a processor unit operatively coupled to the interface unit, the processor unit configured to perform data processing based on the one or more received analyte related data, the processing unit further configured to generate one or more of an alert or a notification for output via the interface unit, where the processor unit is configured to compare the one or more analyte related data to one or more of a predetermined target analyte level, and, in accordance therewith, generate the one or more of the alert or the notification for one or more of an audible output, visual output or a tactile output.

The interface unit may include an input unit and an output unit, the input unit configured to receive the one or more analyte related data, and the output unit configured to output the one or more of the alert of the notification.

The processor unit may be configured to receive substantially, in real time, a plurality of analyte levels of a patient.

The interface unit and the processor unit may be operatively coupled to a housing of an infusion device.

The infusion device may include an external insulin pump.

A system for providing diabetes management in accordance with yet another embodiment includes an analyte monitoring system configured to monitor an analyte level of a patient substantially in real time, a medication delivery unit operatively for wirelessly receiving data associated with the monitored analyte level of the patient substantially in real time from the analyte monitoring system, and a data processing unit operatively coupled to the one or more of the analyte monitoring system or the medication delivery unit, the data processing unit configured to perform data processing based on the monitored analyte level of the patient, and to generate and output one or more of an alert or notification corresponding to the monitored analyte levels.

The analyte monitoring system may be configured to wirelessly communicate with the medication delivery unit over a radio frequency (RF) communication link, a Bluetooth® communication link, an Infrared communication link, or a local area network (LAN).

Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby. 

What is claimed is:
 1. A method of managing hypoglycemia in real time performed by an electronic therapy device, comprising: detecting a pre-sleep time period comprising a time period prior to when a user enters a sleep cycle and entering a pre-sleep mode in response thereto; receiving, automatically without user input and during the pre-sleep time period, a predetermined number of consecutive analyte related level readings for the pre-sleep time period, wherein the predetermined number of consecutive analyte related level readings includes two or more consecutive analyte related level readings; retrieving, automatically without user input and during the pre-sleep time period, a predetermined target analyte level for the pre-sleep time period from a memory; comparing, automatically without user input and during the pre-sleep time period, each of the predetermined number of consecutive analyte related level readings for the pre-sleep time period to the predetermined target analyte level; in response to one or more of the predetermined number of consecutive analyte related level readings being greater than the predetermined target analyte level, exiting the pre-sleep mode and waiting for a subsequent pre-sleep time period; and in response to all of the predetermined number of consecutive analyte related level readings being equal to or lower than the predetermined target analyte level, generating and outputting an alert.
 2. The method of claim 1, further including measuring an analyte related level of the user during the pre-sleep time period to determine the predetermined number of consecutive analyte related level readings.
 3. The method of claim 2, wherein measuring the analyte related level includes using one or more of a discrete blood glucose meter or a continuous analyte monitoring system.
 4. The method of claim 1, further including outputting the alert on a medication delivery unit.
 5. The method of claim 1, wherein the alert includes one or more of an audible alert, a visual alert, or a tactile alert.
 6. The method of claim 5, wherein the visual alert includes one or more of an alphanumeric output display, a graphical output display, an icon display, a video output display, a color display or an illumination display.
 7. The method of claim 1, wherein the pre-sleep time period begins at approximately a predetermined number of hours after the last meal of the day, and terminates at the beginning of entering the sleep cycle.
 8. The method of claim 1, wherein generating the alert includes generating a treatment recommendation.
 9. A system for managing hypoglycemia in real time, comprising: a processor unit coupled to a non-transitory memory, the non-transitory memory comprising a plurality of instructions that, when executed, cause the processor unit to: detect a pre-sleep time period comprising a time period prior to when a user enters a sleep cycle and enter a pre-sleep mode in response thereto; automatically receive, without user input and during the pre-sleep time period, a predetermined number of consecutive analyte related level readings, wherein the predetermined number of consecutive analyte related level readings includes two or more consecutive analyte related level readings; automatically retrieve from the non-transitory memory, without user input and during the pre-sleep time period, a predetermined target analyte level for the pre-sleep time period, automatically compare, without user input and during the pre-sleep time period, each of the predetermined number of consecutive analyte related level readings for the pre-sleep time period to the predetermined target analyte level, in response to one or more of the predetermined number of consecutive analyte related level readings being greater than the predetermined target analyte level, exit the pre-sleep mode and wait for a subsequent pre-sleep time period; and in response to all of the predetermined number of consecutive analyte related level readings being equal to or lower than the predetermined target level, automatically generate and output one or more of an alert and a notification for one or more of an audible output, a visual output and a tactile output.
 10. The system of claim 9, wherein the processor unit is operatively coupled to a housing of an infusion device.
 11. The system of claim 10, wherein the infusion device includes an insulin pump.
 12. A system for managing hypoglycemia in real time, comprising: an analyte monitoring system configured to monitor an analyte level of a user substantially in real time; a medication delivery unit operatively coupled to the analyte monitoring system for wirelessly receiving data associated with the monitored analyte level of the user substantially in real time from the analyte monitoring system automatically without user input; and a data processing unit operatively coupled to one or more of the analyte monitoring system and the medication delivery unit and operatively coupled to a non-transitory memory, the non-transitory memory comprising a plurality of instructions that, when executed, cause the data processing unit to: detect a pre-sleep time period comprising a time period prior to when a user enters a sleep cycle and, upon detection of the pre-sleep time period, enter a pre-sleep mode; automatically receive, without user input and during the pre-sleep time period, a predetermined number of consecutive monitored analyte level readings, wherein the predetermined number of consecutive analyte related level readings includes two or more consecutive analyte related level readings, automatically retrieve from the non-transitory memory, without user input and during the pre-sleep time period, a predetermined target analyte level for the pre-sleep time period, compare automatically, without user input and during the pre-sleep time period, each of the predetermined number of consecutive monitored analyte level readings during the pre-sleep time period to the predetermined target level, in response to one or more of the predetermined number of consecutive analyte related level readings is greater than the predetermined target analyte level, exit the pre-sleep mode and wait for a subsequent pre-sleep time period, and in response to all of the predetermined number of consecutive monitored analyte related level readings being equal to or lower than the predetermined target level, automatically generate and output, without user input and during the pre-sleep time period, one or more of an alert and a notification to the user.
 13. The system of claim 12, wherein the analyte monitoring system is configured to wirelessly communicate with the medication delivery unit over a radio frequency (RF) communication link, a Bluetooth communication link, an Infrared communication link, or a local area network (LAN). 